Franck's Lab Recalls Sterile Sodium Chloride Vials Due to Microbial Contamination
Franck's Lab Inc. is recalling sterile sodium chloride injectable vials because FDA testing found microorganisms and fungal growth in the clean room where the products were prepared.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the injection of sterile drugs contaminated with microorganisms and fungal growth, which presents a significant risk of serious injury or hospitalization.
Plain-English summary
Franck's Lab Inc., d.b.a. Franck's Compounding Lab, is recalling 27 units of Bacteriostatic Sodium Chloride 0.9% Injectable vials. The affected products include various sizes, such as 10 ml, 20 ml, 30 ml, 40 ml, 50 ml, 100 ml, and 200 ml vials. These sterile human drugs were distributed between November 21, 2011, and May 21, 2012.
The recall was initiated because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where the sterile products were prepared. This lack of assurance of sterility poses a risk to patients who may have received the contaminated injectable solutions.
The products were distributed nationwide and to several international locations, including the Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and the West Indies. Patients and healthcare providers should check their records for prescriptions matching the listed Rx numbers and contact their healthcare provider or the recalling firm for further instructions on how to proceed.
The recalled product
- Product
- BACTERIOSTATIC SODIUM CHLORIDE 10ML VIAL** 0.9% INJECTABLE 10 ML, 10 MLS, 100 ML, 120, 20 MLS, 200 ML, 30 MLS, 40 ML, 50 ML, 50 MLS (10 DIFFERENT PRODUCTS)
- Affected units
- 27
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Rx #'s: 0404160
- 0404162
- 0404697
- 0405589
- 0407510
- 0407568
- 0407772
- 0409510
- 0409877
- 0410186
- 0404478
- 0405838
- 0406815
- 0406819
- 0405467
- 0407857
- 0404470
- 0404712
- 0406839
- 0406523
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 100 recalled by Franck's Lab Inc., d.b.a. Franck's Compounding Lab under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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